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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEVICOR MEDICAL PRODUCTS, INC. HYDROMARK BREAST BIOPSY SITE MARKER

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DEVICOR MEDICAL PRODUCTS, INC. HYDROMARK BREAST BIOPSY SITE MARKER Back to Search Results
Model Number 4010-02-15-T4
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 09/11/2018
Event Type  Injury  
Manufacturer Narrative
The hydromark biopsy site identifier is a sterile, single use device intended for use after an open surgical or percutaneous breast biopsy procedure to mark the biopsy site. The device is not available for analysis, which precludes a full investigation and analysis of the root cause. We are submitting this report based upon the patient consequence of an unidentified fragment in the biopsy site, and the likely additional surgical procedure to remove the fragment.
 
Event Description
Devicor medical products inc. Received a complaint from user stating, during the procedure a fragment was noted in the breast not in the path of hydromark. Fragment was posterior. Follow up with the user facility indicates they believe the fragment to be the tip of the needle used to administer the lidocaine. No patient complications. We have documented this as record (b)(4).
 
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Brand NameHYDROMARK BREAST BIOPSY SITE MARKER
Type of DeviceBIOPSY SITE MARKER
Manufacturer (Section D)
DEVICOR MEDICAL PRODUCTS, INC.
300 e. business way
fifth floor
cincinnati OH 45241
Manufacturer (Section G)
DEVICOR MEDICAL PRODUCTS DE MEDICAL
sor juana ines de la cruz
#20152 4-b, parque industrial
tijuana, baja california
Manufacturer Contact
jill burnett
300 e. business way
cincinnati, OH 45241
5138649047
MDR Report Key7958249
MDR Text Key123486868
Report Number3008492462-2018-00079
Device Sequence Number1
Product Code NEU
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K130537
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 09/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/11/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number4010-02-15-T4
Device Catalogue Number4010-02-15-T4
Device Lot NumberF11815501D
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/11/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/11/2018 Patient Sequence Number: 1
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